Thursday, January 05, 2023 9:31:10 PM
Hello JamesF1, the pivotal bioequivalence PR in my previous post is in fact referring to a generic version of the currently-marketed ADF OxyContin. The bioequivalence studies have been done, and the ANDA application was submitted in 2017. I would hope any bio-equivalency issues have been resolved by now. I believe what is preventing the application from moving forward is the lack of human abuse liability studies. The company has to prove our generic formula is just as difficult to abuse as the brand name, but exactly what that means is uncertain because the FDA has not yet approved any generics of ADF OxyContin or any other brand name ADF. Now that cash is available, the missing HAL studies can be pursued. It is unknown how many companies have already gotten in line with completed HAL studies or when the FDA will actually give one of them an approval. At least 4 companies, including Epic, have already beaten Purdue et al in patent court.
Sep 20, 2017:
#FreeSequestOx
#FreeTacoForShareholders
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